Your session is about to expire
← Back to Search
Behavioral Intervention
Multilevel HIV Prevention Strategy for Increasing PrEP Uptake (STARR-NC Trial)
N/A
Recruiting
Led By Sarah Rutstein, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
STARR-NC Trial Summary
This trial will study a multilevel HIV prevention strategy in NC clinics to improve PrEP uptake and reduce HIV infections.
Who is the study for?
This trial is for individuals assigned male at birth, aged 18-39, who have had sexual activity with a male in the past year and are not currently using PrEP. They must speak English, have daily smartphone access, and have tested HIV-negative within the last 90 days.Check my eligibility
What is being tested?
The study tests a strategy to increase PrEP use among participants. It includes randomized trials of PrEP Navigation Services, two versions of HealthMpowerment Digital Health Intervention (basic and enhanced), and Telehealth referrals over three years in rural North Carolina STI clinics.See study design
What are the potential side effects?
While specific side effects are not listed for this intervention strategy as it focuses on service delivery methods rather than medication directly, typical PrEP medications can cause nausea, headache, stomach pain or weight loss.
STARR-NC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants reporting PrEP initiation by 3 months
Secondary outcome measures
Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 3-month visit.
Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 6-month visit.
Average number of consecutive months PrEP used over first 3 months
+18 moreSTARR-NC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STARR NC Intervention ConditionExperimental Treatment3 Interventions
Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care.
The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement.
Intervention Arm participants will complete baseline and quarterly follow-up assessments.
Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.
Group II: STARR NC Standard-of-Care Control ConditionActive Control1 Intervention
Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform.
The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center.
Control Arm participants will complete baseline and quarterly follow-up assessments.
Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,489 Total Patients Enrolled
4 Trials studying PrEP
3,390 Patients Enrolled for PrEP
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,901 Total Patients Enrolled
1 Trials studying PrEP
300 Patients Enrolled for PrEP
Sarah Rutstein, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
464 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 39 years old.I have used PrEP medication in the last 3 months.I have been sexually active with a male in the last year.I was assigned male at birth.I am not currently using PrEP.
Research Study Groups:
This trial has the following groups:- Group 1: STARR NC Intervention Condition
- Group 2: STARR NC Standard-of-Care Control Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I register to be a participant in this experiment?
"To be considered for this study, prospective participants must meet the age requirements of 18 to 39 years and have no prior medical complications. Currently, approximately 336 people are being recruited."
Answered by AI
Does this research accept participants younger than 35 years old?
"Participants who are between 18 and 39 years old are eligible for this medical trial."
Answered by AI
Is there availability for individuals to participate in the research?
"Per the details available on clinicaltrials.gov, this particular research project is no longer accepting participants. The trial was first listed in August of 2023 and revised most recently on August 1st of that same year. Despite being closed to recruitment there are currently 1 other trials seeking enrollees."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger